An Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis

• Sponsor: Samsung Bioepis Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02565810
• Collaborator: (none)
• Enrollment: 49
• Locations: 2
• Arm: 1
• Duration (Months): 6
• Patients Per Site: 24.5
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Adalimumab PFS and Pen	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SB5 40mg	Drug: Adalimumab PFS and Pen

Outcome Measures

Primary Outcome Measures

1. The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale [Difference of injection site pain score (Week 6 - Week 2)]

   Injection site pain evaluation questionnaire will be rated on an 11-point numeric rating scale ranging from 0 (no pain) to 10 (pain as bad as it could be) at two-time points post-injection (immediately post-injection and between 15 to 30 minutes post-injection) at Weeks 0, 2, 4, and 6.

Secondary Outcome Measures

1. Overall Impression of SC Delivery Administration of SB5 Using Questionnaire [at Week 2 and at Week 6]

   Objective: To evaluate whether overall impressions of SC administrations at Week 2 and Week 6 were comparable between the SC administrations of SB5 via the Pen and via the PFS.

2. Subject Preference of SC Delivery Administration of SB5 Using Questionnaire [at Week 6]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Are male or female aged 18-55 years at the time of signing the informed consent form.

2. Have been diagnosed as having RA according to the revised 1987 American College of Rheumatology (ACR) criteria for at least 6 months prior to Screening.

3. Subjects who are considered by the Investigator to be a suitable candidate for self-administering adalimumab treatment

4. Must be able to provide informed consent, which must be obtained prior to any study related procedures.

Exclusion Criteria:

1. Have been treated previously with any biologic agents including any tumour necrosis factor inhibitor.

2. Have a known hypersensitivity to human immunoglobulin proteins or other components of SB5.

3. Have a current diagnosis of active tuberculosis (TB), have been recently exposed to a person with active TB, or are considered to have latent TB indicated by a positive QuantiFERON® Gold test result.

4. Have had a serious infection (such as sepsis, abscess, opportunistic infections or invasive fungal infection including histoplasmosis) or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to first dose of IP. Nonsignificant infections do not need to be considered exclusionary at the discretion of the Investigator.

5. Have a history of chronic or recurrent infection (such as chronic renal infection, chronic chest infection or recurrent urinary infection).

6. Have any of the following conditions:

7. History of congestive heart failure (New York Heart Association Class III/IV)

8. History of demyelinating disorders (such as multiple sclerosis or Guillain-Barré syndrome).

9. History of any malignancy (other than lymphoproliferative disease and melanoma, see Exclusion Criteria 10.f) within the previous 5 years prior to Screening except completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.

10. History of lymphoproliferative disease including lymphoma or melanoma.

11. Any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Gdynia	Gdynia		Poland
2	Medica pro Familia Sp z o.o. S.K.A Oddzial Warszawa	Warszawa		Poland

Sponsors and Collaborators

• Samsung Bioepis Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsung Bioepis Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02565810
• Other Study ID Numbers: SB5-G21-RA
• First Posted: Oct 1, 2015
• Last Update Posted: Apr 1, 2019
• Last Verified: Dec 1, 2018

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Adalimumab

Study Results

Participant Flow

Arm/Group Title	SB5 40mg
Arm/Group Description	Adalimumab PFS and Pen
Period Title: Overall Study
STARTED	49
COMPLETED	48
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	SB5 40mg
Arm/Group Description	Adalimumab PFS and Pen
Overall Participants	49
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.9 (9.08)
Sex: Female, Male (Count of Participants)
Female	39 79.6%
Male	10 20.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	49 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	49 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Height (cm) (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	167.69 (8.799)

Outcome Measures

1. Primary Outcome

Title	The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale
Description	Injection site pain evaluation questionnaire will be rated on an 11-point numeric rating scale ranging from 0 (no pain) to 10 (pain as bad as it could be) at two-time points post-injection (immediately post-injection and between 15 to 30 minutes post-injection) at Weeks 0, 2, 4, and 6.
Time Frame	Difference of injection site pain score (Week 6 - Week 2)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SB5 Pen/PFS
Arm/Group Description	Injection via PFS at Week 0 and Week 2 and then injection via Pen st Week 4 and then every other week thereafter up to Week 10
Measure Participants	49
Immediately post-injection	-0.35
15-30 min post-injection	-0.11

2. Secondary Outcome

Title	Overall Impression of SC Delivery Administration of SB5 Using Questionnaire
Description	Objective: To evaluate whether overall impressions of SC administrations at Week 2 and Week 6 were comparable between the SC administrations of SB5 via the Pen and via the PFS.
Time Frame	at Week 2 and at Week 6

Outcome Measure Data

Analysis Population Description

Only number of subjects with available assessment results at each visit were counted as 'Overall number of participants analyzed'.

Arm/Group Title	Week 2 (SB5 40 mg PFS)	Week 6 (SB5 40 mg Pen)
Arm/Group Description	40 mg sc injection via PFS at Week 0 and Week 2 and then 40 mg sc injection via Pen st Week 4 and then every other week thereafter up to Week 10.	40 mg sc injection via PFS at Week 0 and Week 2 and then 40 mg sc injection via Pen st Week 4 and then every other week thereafter up to Week 10.
Measure Participants	48	46
Extremely Favorable	1 2%	3 NaN
Favorable	13 26.5%	15 NaN
Neutral	31 63.3%	21 NaN
Unfavorable	3 6.1%	7 NaN
Extremely Unfavorable	0 0%	0 NaN

3. Secondary Outcome

Title	Subject Preference of SC Delivery Administration of SB5 Using Questionnaire
Time Frame	at Week 6

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed means number of subjects with available assessment results

Arm/Group Title	SB5 PFS	SB5 Pen	No Preference
Arm/Group Description	Subject preference for the PFS at Week 6	Subject preference for the Pen at Week 6	Subject who chose 'no preference' at Week 6
Measure Participants	46	46	46
Overall Preference	14	26	6
Category: Ease of Use	10	33	3
Category: Convenience	6	35	5
Category: Time to Administer Injection	9	30	7
Category: Safety	6	31	9
Category: Less Pain	17	21	8

Adverse Events

Arm/Group Title	SB5 40mg
Arm/Group Description	Adalimumab PFS and Pen
All Cause Mortality
	SB5 40mg
	Affected / at Risk (%)	# Events
Total	0/49 (0%)
Serious Adverse Events
	SB5 40mg
	Affected / at Risk (%)	# Events
Total	0/49 (0%)
Other (Not Including Serious) Adverse Events
	SB5 40mg
	Affected / at Risk (%)	# Events
Total	4/49 (8.2%)
Infections and infestations
Nasopharyngitis	4/49 (8.2%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.